MicroPace StimLab Operator's manual

ENGLISH
USER INSTRUCTION MANUAL
Micropace Cardiac Stimulators
EPS320B/BT
StimCor™
StimLab™

ENGLISH
Distributed by:
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
USA
USA Customer Service 888-272-1001
AND
GE Medical Systems Information Technologies
8200 West Tower Ave
Milwaukee, WI 53223
U.S.A
Micropace Pty Ltd.
41/159 Arthur Street
Homebush West, NSW 2140
Australia
www.micropaceEP.com/euar.html
CAUTION
US Federal Law restricts this device to sale
by or on the order of a physician.
Micropace Cardiac Stimulators
User Instruction Manual
EPS320 & StimCor™ & StimLab™ Micropace Part Order No. MP3425
Compact Version English 1.3
Valid for:
Stimulator Software version 4.0
SGU Firmware versions 4.76
Advena Ltd, Tower Business Centre, 2nd
Flr.,
Tower Street, Swatar, BKR 4013, Malta

USER INSTRUCTION MANUAL
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Table of Contents
1
1 INTRODUCTION & ESSENTIAL PRESCRIBING INFORMATION .................................................. 1
1.1 DEVICE DESCRIPTION .................................................................................................................... 1
1.1.1 Description of Stimulator ..................................................................................................... 1
1.1.2 Accompanying Documentation ........................................................................................... 1
1.1.3 Intended Use ....................................................................................................................... 1
1.1.4 Indications for Use .............................................................................................................. 1
1.1.5 Operating Environment ....................................................................................................... 1
1.1.6 Contraindications ................................................................................................................ 2
1.2 COMPATIBLE EQUIPMENT .............................................................................................................. 2
1.3 IMPORTANT PATIENT SAFETY WARNINGS ....................................................................................... 2
1.3.1 General Warning ................................................................................................................. 2
1.3.2 Warnings Specific to the Micropace Stimulator .................................................................. 3
1.3.3 Warnings Related to the use of Micropace Stimulator with RF Ablation Equipment .......... 3
1.4 GENERAL PRECAUTIONS IN HANDLING STIMULATOR ....................................................................... 4
2
2 DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION ....................................................... 6
3
3 COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE ................................................................ 7
4
4 EXPLANATION OF SYMBOLS ......................................................................................................... 8
5
5 EPS320 FAMILY OF CARDIAC STIMULATORS ........................................................................... 13
5.1 DESCRIPTION OF STIMULATOR FAMILY ......................................................................................... 13
6
6 EPS320B/BT CONFIGURATION .................................................................................................... 14
6.1 DESCRIPTION OF SYSTEM ............................................................................................................ 14
6.2 SYSTEM COMPONENTS ............................................................................................................... 14
6.3 EPS320B/BT OPTIONAL INSTALLATION ACCESSORIES ................................................................. 17
7
7 STIMCOR™ CONFIGURATION ...................................................................................................... 18
7.1 DESCRIPTION OF SYSTEM ............................................................................................................ 18
7.2 HOW SUPPLIED ........................................................................................................................... 18
7.3 SYSTEM COMPONENTS ............................................................................................................... 19
7.4 STIMCOR™ OPTIONAL INSTALLATION ACCESSORIES .................................................................... 19
8
8 STIMLAB™ CONFIGURATION ...................................................................................................... 20
8.1 DESCRIPTION OF SYSTEM ............................................................................................................ 20
8.2 HOW SUPPLIED ........................................................................................................................... 20
8.3 SYSTEM COMPONENTS ............................................................................................................... 21
8.4 STIMLAB™ OPTIONAL INSTALLATION ACCESSORIES ..................................................................... 22
9
9 INSTALLATION ............................................................................................................................... 22
1
10 0 USING THE MICROPACE CARDIAC STIMULATORS .................................................................. 23
10.1 CONNECTING THE STIMULUS CONNECTION BOX ........................................................................... 23
10.2 SWITCHING ON THE SYSTEM ........................................................................................................ 23
10.3 USING THE COMPUTER ................................................................................................................ 23
10.4 SETTING UP THE COMPUTER ........................................................................................................ 24
10.5 INDICATING LOCATION OF SGU .................................................................................................... 24
1
11 1 USING THE KEYBOARD AND THE TOUCH DISPLAY ................................................................ 25
11.1.1 Numeric Keypad................................................................................................................ 27
11.2 USING THE STIMLAB™ BEDSIDE CONTROLLER FEATURES ............................................................ 28
11.2.1 Input Device Control ......................................................................................................... 28
11.2.2 Local/Remote Indicator: .................................................................................................... 28
1
12 2 USING THE STIMULATOR SOFTWARE ....................................................................................... 29
12.1 HELP FUNCTION .......................................................................................................................... 29
12.2 TRAINING VIDEOS ....................................................................................................................... 29
12.3 HELP SEARCH............................................................................................................................. 29
12.4 THE MAIN STIMULATOR SCREEN .................................................................................................. 29
12.5 PACING PARAMETERS ................................................................................................................. 29
12.6 BASIC PACING ............................................................................................................................ 30

CARDIAC STIMULATOR
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12.7 USING THE STIMULATOR SOFTWARE PROTOCOLS......................................................................... 31
12.8 PACING PROTOCOLS ................................................................................................................... 32
12.8.1 Protocol Selection & Renaming ........................................................................................ 32
12.8.2 Pace Protocols .................................................................................................................. 32
12.8.3 Threshold Protocol ............................................................................................................ 32
12.8.4 Nodal_ERP Protocol ......................................................................................................... 33
12.8.5 Multi_Sx Protocol .............................................................................................................. 33
12.8.6 Wenckebach Protocol ....................................................................................................... 33
12.8.7 RSynced_Sx Protocol ....................................................................................................... 33
12.8.8 SNRT* Protocol ................................................................................................................. 34
12.8.9 Burst_Pace Protocol ......................................................................................................... 34
12.8.10 AV Atrio-ventricular Delayed Protocol............................................................................... 34
12.8.11 Overdrive Pace and ATP Protocols .................................................................................. 34
12.8.12 Specialised Protocols ........................................................................................................ 35
12.9 SOFTWARE CONFIGURATION. ....................................................................................................... 37
12.10 SOUND CONFIGURATION ............................................................................................................. 37
12.11 SAFETY FEATURES...................................................................................................................... 37
12.12 SOFTWARE ERROR MESSAGES .................................................................................................... 38
12.13 ADDITIONAL SOFTWARE MESSAGES ............................................................................................. 39
12.13.1 Advisory Messages ........................................................................................................... 39
12.13.2 Text Messages .................................................................................................................. 41
12.14 CONFIGURING THE PROGRAM - THE CONFIG MENU ..................................................................... 42
1
13 3 THE EPS320 STIMULUS GENERATOR UNIT ............................................................................... 44
13.1 EPS320 STIMULUS GENERATOR UNIT LAYOUT............................................................................. 44
13.2 EPS320 STIMULATOR CONNECTIONS .......................................................................................... 45
13.3 HARDWARE ERROR MESSAGES ON THE EPS320 STIMULUS GENERATOR UNIT.............................. 46
1
14 4 TROUBLESHOOTING ..................................................................................................................... 48
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15 5 MAINTENANCE ............................................................................................................................... 49
15.1 BATTERIES ................................................................................................................................. 49
15.2 MAINTENANCE AND CALIBRATION ................................................................................................. 49
15.3 CLEANING INSTRUCTIONS ............................................................................................................ 49
15.4 SERVICEABLE LIFE AND DISPOSAL ............................................................................................... 49
Tables
TABLE 1 EXPLANATION OF SYMBOLS ......................................................................................................... 10
TABLE 2 EXPLANATION OF SYMBOLS – SPECIFIC TO THE SGU. ................................................................... 12
TABLE 3 LIST OF AVAILABLE INSTALLATION ACCESSORIES FOR THE EPS320B/BT CARDIAC STIMULATOR. ... 17
TABLE 4 LIST OF AVAILABLE INSTALLATION OPTIONS FOR THE STIMLAB™ CARDIAC STIMULATOR SYSTEM. .. 22
TABLE 5 COMPUTER FRONT PANEL EXPLANATIONS ................................................................................... 23
TABLE 6 TOUCH BUTTONS, TOUCH ZONES AND THEIR FUNCTIONS ................................................................ 27
TABLE 7 ADVISORY MESSAGES AND SUGGESTED ACTIONS. .......................................................................... 41
TABLE 8 CONFIGURATION MENU PAGE ..................................................................................................... 43
TABLE 9 TABULATED ERROR MESSAGES ..................................................................................................... 47
Figures
FIGURE 1: EPS320B/T, STIMCOR™ AND STIMLAB™ ............................................................................... 13
FIGURE 2 EPS320BT SYSTEM COMPONENTS ........................................................................................... 14
FIGURE 3 EPS320BT QUICK INSTALLATION GUIDE .................................................................................. 16
FIGURE 4 STIMCOR™ SYSTEM COMPONENTS .......................................................................................... 18
FIGURE 5 STIMCOR QUICK INSTALLATION GUIDE ...................................................................................... 19
FIGURE 6 STIMLAB™ SYSTEM COMPONENTS ........................................................................................... 20
FIGURE 7 STIMLAB™. QUICK INSTALLATION GUIDE .................................................................................... 21
FIGURE 8 COMPUTER FRONT PANEL FOR EPS320B/BT (LEFT) AND STIMLAB / STIMCOR (RIGHT) ................ 23
FIGURE 9 KEYBOARD LAYOUT .................................................................................................................. 25

USER INSTRUCTION MANUAL
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FIGURE 10 TOUCH SCREEN ...................................................................................................................... 25
FIGURE 11 HELP MENU ............................................................................................................................ 29
FIGURE 12 STIMULATOR USER INTERFACE SCREEN SET TO PACE PROTOCOL. ........................................... 30
FIGURE 13 STIMULATION PATTERNS IN BASIC PACING PROTOCOLS. ............................................................ 31
FIGURE 14 PROTOCOL TOOLBOX .............................................................................................................. 32
FIGURE 15 FOR URGENT PACING .............................................................................................................. 37
FIGURE 15 THE EPS320 STIMULUS GENERATOR UNIT FRONT PANEL ......................................................... 44
FIGURE 16 CONNECTORS ON REAR PANEL OF SGU (REFERENCE ONLY) ..................................................... 45

CARDIAC STIMULATOR
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Glossary and Terms
Term Explanation
Drive Train Also called S1; the 6-8 regular pacing stimuli before any extra-stimuli is applied.
ECG Electrocardiogram
EP Electrophysiology
IECG Intra-cardiac Electrocardiogram
LCD Liquid Crystal Display
LED Light Emitting Diode
P/QRS P wave or QRS; also signifies any IECG waveform.
PC Personal Computer
RA Right Atrium
RV Right Ventricle
RF Radiofrequency, e.g. RF Ablation
RR R-R interval on ECG or peak-to-peak interval on IECG.
S1 Basic stimulation interval.
SGU Micropace Stimulus Generator Unit
SM-Box Stimulus Multiplexer Box – converts EPS320 two stimulus output channels to
four channels.
SNRT Sinus Node Recovery Times
StimLink™ Communication cable for connection to EP Recording Equipment
Sx The name for and the coupling interval of one or more extra-stimuli added after
Drive Train called S2, S3…S7.
GUI Graphical User Interface

CARDIAC STIMULATOR
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1
1 INTRODUCTION & ESSENTIAL PRESCRIBING
INFORMATION
1.1 Device Description
1.1.1 Description of Stimulator
Micropace cardiac stimulator systems are all based on the EPS320 cardiac stimulator, a diagnostic
external programmable cardiac stimulator.
The description of each system is described in its own section below.
1.1.2 Accompanying Documentation
 User Instruction Manual (Instructions for Use), this document.
 Technical Description, which includes installation instructions and advanced usage information
(English-only, included in full English UIM MP3395).
 Accessories Unit Contents and Instructions for Use Leaflet
 Service Manual is available on request
It is strongly recommended that the Operator reads the User Instruction Manual document in
its entirety and is familiar with its contents before using the Stimulator on patients.
1.1.3 Intended Use
The Micropace Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the
heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and
measurements of electrical conduction.
1.1.4 Indications for Use
The Stimulator system is an electrical stimulus generator for diagnostic cardiac stimulation during
electrophysiological testing of the human heart.
1.1.5 Operating Environment
The stimulator is intended for use in air conditioned hospital cardiac electrophysiology laboratories
equipped for advanced cardiac resuscitation, by technicians trained in diagnostic cardiac stimulation
under constant supervision by a cardiologist. Stimulator parts Remote Station MP3168 and connection
boxes MP3086 and MP3014 may be used in the patient environment, but must be protected from
ingress of fluids. The required installation and electromagnetic environment is described in the
Technical Manual.
Device is not intended for use with flammable gasses of liquids, no part of it is sterile or sterilizable
and device is not protected from ingress of fluids.
Warning: Do not stack EPS320 components or use them directly adjacent with other equipment. If
adjacent or stacked use is necessary, verify normal operation in the configuration per the system
verification instructions in this IFU.

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1.1.6 Contraindications
Do not use the Stimulator system for life support in patients with life-threatening bradycardia; use
instead temporary external pacemaker.
1.2 Compatible Equipment
The primary function of the Micropace Cardiac Stimulator is the generation of constant current
rectangular stimulation pulses with amplitudes of 0.1mA to 25mA, duration of 0.5ms to 10ms and with
a maximum voltage of ± 27V. Third party switching equipment with the following special characteristics
must be used to carry the stimulus pulses to the intracardiac electrodes without significant distortion:
 Series resistance: < 100 Ohms at up to ± 25mA
 Shunt resistance: > 100,000 Ohms at up to ± 27V
 Frequency bandwidth: DC to 300 Hz
 Interference RF energy sources: < 350Vpp at 400 kHz to 600 kHz, or 150W into a 300 Ohm
load
Micropace Stimulator is intended for use with the following equipment;
Diagnostic and Ablation pacing electrode catheters
 Currently available legally marketed electrophysiological diagnostic electrode catheters,
including those manufactured by Cordis Biosense Webster, Daig, CR Bard, Medtronic and
EPT.
EP Recording equipment
 Computerized EP Recording systems manufactured by Bard Electrophysiology (LabSystemTM
DuoTM and LS ProTM) and GE/Prucka (CardioLab 4000, 7000) have been tested for use with
the EPS320 Stimulator.
1.3 Important Patient Safety Warnings
1.3.1 General Warning
Warning: Stimulator must be used only under supervision by a cardiologist.
 To avoid death or injury to patient from arrhythmias, the Stimulator may be used on humans
only under the direct supervision by a physician familiar with electrophysiology in an
appropriate hospital facility.
 The supervising physician must verify all Stimulator settings immediately prior to
commencement of pacing.
Warning: Installation and use only by qualified personnel.
 Only qualified personnel, such as representatives of Micropace Pty Ltd, its authorized
distributor or hospital-appointed biomedical engineers, may carry out installation of the
Stimulator system and its connection to other equipment.
 In order to reduce operator errors, installation, configuration and customer training should be
performed in a manner, which allows optimal use of the Stimulator by the user.
Warning: Stimulator is not a life support device – operator must have available backup
temporary external pacemaker.
 To avoid injury to patient from bradycardia, operator must have available a backup temporary
external pacemaker.

CARDIAC STIMULATOR
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Warning: Stimulator must use isolated mains supply only.
 To avoid electrocution hazards, all parts of the Stimulator, including the computer, monitor and
Stimulus Generator Unit must all be connected to the Mains Isolation Transformer and never
directly to a mains power outlet.
Warning: To avoid electrocution hazards, connect Stimulator system only to legally marketed,
mains-isolated electrical equipment.
 Connect Stimulator only to parts specified by Micropace as compatible or to equipment
certified to IEC 60601-1.
 Do not connect equipment other than that specified by Micropace to the multiple socket outlets
on the Micropace supplied Isolation Transformer.
 If this equipment is modified, appropriate inspection and testing, including IEC 60601-1:2005,
must be conducted to ensure continued safe use of the equipment.
 Avoid connecting equipment parts to patient by touching simultaneously conductive part of this
or other equipment and the patient.
Warning: Use Stimulator only in ventilated areas and away from flammable gasses.
 To avoid risk of explosion, the Stimulator should only be used in a ventilated area as gasses
may be released during charging of backup battery, and should not be used in rooms with
flammable anesthesia.
1.3.2 Warnings Specific to the Micropace Stimulator
Warning: Monitor function of Stimulator and patient’s vital signs continuously.
 The Micropace Stimulator may fail to stimulate or unintentionally stimulate the patient through
software, hardware or human error. To avoid injury to patient from arrhythmias, monitor the
function of Stimulator and patient’s vital signs continuously while Stimulator is connected to
the patient.
 In case of repeated recurrence of unexplained life-threatening arrhythmias despite
cardioversion/defibrillation during the use of the Stimulator, disconnect the Stimulator from the
patient by unplugging the green Pace Output plug on the front panel in case it has an occult
malfunction causing recurrent micro-electrocution or recurrent DC current stimulation.
Warning: Measurements by Stimulator are for information only.
 Measurements displayed by Stimulator, including the Impedance measurement, RR interval
and SNRT measurement are for facilitation of use of Stimulator. The user should use third
party legally marketed measurement devices independent of the Stimulator to measure these
parameters for the purpose of clinical diagnoses.
Warning: When using the optional Four Channel Stimulus Multiplexer Box (SM-Box)
 Product is not suitable for sterilization and must be protected from ingress of fluids
 In order to prevent inadvertent or ineffective pacing, the user should always verify the actual
channel being paced using independent EP Recording Equipment.
1.3.3 Warnings Related to the use of Micropace Stimulator with RF Ablation
Equipment
Warning: Use Stimulator only with RF-filtered stimulus connection. (Micropace parts: MP3014,
MP3086).

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 Use only supplied Stimulus Connection Box (MP3014) or optional Stimulus Multiplexer Box
(MP3086) components to connect Stimulator’s stimulus output to patient circuits.
 The MP3014 and MP3086 components are over voltage protected by gas arrestors for
differential voltages > 350VAC. Exposing these components to unfiltered RF ablation energies
exceeding this limit (e.g. by direct connection to unfiltered RF Ablation energies > 150W or
ablating into > 300 Ohm loads may cause reduction of RF energy available for ablation and
overheating and a fire hazard within these components.
Warning: Do not stimulate via ablation electrode during delivery of RF Ablation energy.
 To avoid possibility of unintended arrhythmia induction, do not stimulate myocardium via the
ablation electrode during application of RF energy. Efficacy and potential for adverse effects of
stimulation of heated myocardium in the process of ablation have not been established.
1.4 General Precautions in Handling Stimulator
Caution: Installation, Transport, and Storage.
 To ensure reliable operation of the Stimulator, install it in a well-ventilated place away from
dust, excessive heat or humidity, direct sunlight and splashing liquids.
 To ensure operator may see important error messages displayed during operation, install with
the front panel of the Stimulus Generator Unit visible to the Operator.
 To avoid damage to the Stimulator, avoid exposure to chemical gases, excessive vibration,
impact, temperatures above 60 Deg. Celsius or ambient air pressures equivalent to above
10000m altitude during transport and handling.
 To ensure that backup battery remains fully charged, store system between uses with the
Stimulus Generator Unit connected to mains power supply, switched on at the rear panel
switch.
 Assembly and modification of this Medical System during the actual service life requires
evaluation to the requirements of IEC 60601-1:2005.
Caution: Precautions prior to use.
 When turning on the SGU, ensure all LEDs illuminate during the Power On Self Test and no
error messages are displayed, else refer to Troubleshooting section below.
 Ensure that all cables are properly installed and secured.
 Ensure that the mains power supply is isolated and that attached equipment is also electrically
isolated and does not pose an electrical hazard.
 If the Stimulator has been unused or may have been disconnected from mains power supply
for more than 1 month, charge backup battery by leaving connected to the mains supply in
Standby Mode overnight.
 Do not use the Stimulator if any component appears damaged, computer appears to start up
abnormally, or error messages appear on the computer screen or Stimulator front panel. If in
doubt, contact the Distributor or Micropace directly.
 Ensure that the Operator is trained thoroughly on how to switch the Stimulator to Backup
Manual mode or Emergency Fixed Rate Pacing modes.
 To prevent custom software malfunction, do not install other software.
Caution: Precautions during use.